West Cancer Center

BLADDER: METASTATIC: RECEIVING IMMUNOTHERAPY: 12-15 months without growth: A031901

Duration of Immune Checkpoint Therapy in Locally Advanced or Metastatic Urothelial Carcinoma: A Randomized Phase 3 Non-Inferiority Trial

Title

Alliance: A031901 (Bladder stop IO)

Study Title

Duration of Immune Checkpoint Therapy in Locally Advanced or Metastatic Urothelial Carcinoma: A Randomized Phase 3 Non-Inferiority Trial

Site Link

NCT04637594

Malignancy

Bladder Cancer, Urothelial Carcinoma, Transitional Cell, Renal Pelvis, ureter, urethra

Stage

Stage 4

Disease Setting

Metastatic/Palliative

Line Of Therapy

After 1st or 2nd line

Investigational Agent

Pembrolizumab, Nivolumab, Atezolizumab, Durvalumab, Avelumab, or Discontinuation

Drug Class

N/A

Dan Vaena, MD

Sponsor

Alliance for Clinical Trials in Oncology

Phase

Phase 3

Status

Closed to Accrual

Key Eligibility Criteria

Key Eligibility Criteria Details

Histologically or cytologically confirmed urothelial carcinoma with predominantly transitional-cell features
Locally advanced or metastatic disease before starting ICI therapy
Must be receiving current active treatment with SOC FDA approved PD-1/L1 ICI containing therapy
Tumor decrease (either in target or non-target lesions) after 12-15 months on ICI. Does not need to be formal PR/CR. Any decrease confirmed by repeat scan 4 weeks later is OK
ECOG PS 0-2
Adequately treated CNS disease is eligible
No current immunosuppresive drugs

Objective

Assessment Frequency

Assessment Frequency 2

Assessment Frequency Link

Path

Urothelial carcinoma with predominantly transitional-cell features

Dosing Frequency

Control Agents

Study Protocol

Randomized

Yes